|
Catalog Number UNKNOWN |
Device Problems
Fracture (1260); Misfire (2532)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/03/2022 |
Event Type
malfunction
|
Event Description
|
It was reported during a stent graft placement procedure through cephalic vein, the device allegedly had a partial deployment.It was further reported that the device was removed from the patient.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.Device not returned.
|
|
Event Description
|
It was reported during a stent graft placement procedure through cephalic vein, the device allegedly had a partial deployment.It was further reported that the device blue outer sheath separation close to the handle.Reportedly, the device was removed from the patient.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the fda rn number for the mdr 9681442-2022-00251 was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
|
|
Search Alerts/Recalls
|
|
|